BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH NEONATAL PICC

    MDR report key: 4220534 · Received August 6, 2014

    Report

    Report Number
    2245270-2014-00065
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 5, 2014
    Manufacturer
    VYGON GMBH.
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE FOUR OCCURRENCES OF THIS COMPLAINT FROM THIS CUSTOMER. PLEASE REFERENCE THE FOLLOWING MDR FOR INFO CONCERNING THE ADDITIONAL OCCURRENCES: 2245270-2014-00062; 00063; 00064. THE COMPLAINT AND RETURNED SAMPLES WERE SUBMITTED TO VYGON (B)(4), THE MFR, FOR EVALUATION AND INVESTIGATION. AFTER CONDUCTING A THOROUGH INVESTIGATION INTO THIS CLAIM VYGON CANNOT CONFIRM A QUALITY PROBLEM WITH THIS PRODUCT. EXAMINATION OF THE FIRST DEFECTIVE DEVICE SHOWED THE CATHETER WAS CUT AT 2CM DISTAL TO ITS FIXATION WING. THE SECOND DEFECTIVE DEVICE WAS CUT AT 1CM TO ITS FIXATION WING. RADIAL CURVED STRIATIONS WERE VISIBLE ON BOTH SAMPLES. THIS DEFECT IS CONSISTENT WITH INADVERTENT CUTTING OF CATHETERS DURING DRESSING CHANGE. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME, BUT THIS INCIDENT WILL BE PLACED IN OUR COMPLAINT SYSTEM. WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF PROBLEM.

    Description of Event or Problem · 1

    CATHETER WAS IN USE FOR SEVERAL DAYS BEFORE LEAKAGE WAS OBSERVED. THE LEAK WAS FOUND AFTER A 96 HOUR DRESSING CHANGE BELOW THE WINGS. THE DRESSING CHANGE CONSISTS OF SALINE SITE PREP AND TEGADERM DRESSING CHANGE. THIS OCCURRED FOUR TIMES WITH THIS CATHETER AT THIS FACILITY. THE CUSTOMER SAVED TWO SAMPLES, AND SUBMITTED THEM TO VYGON. NO PT INJURY WAS REPORTED AS A RESULT OF THE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460556 PREMICATH NEONATAL PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH. 1261.203G 140214GC

    Patients

    Seq Age Sex Outcome Treatment
    1